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Live oral rotavirus vaccines (LORVs) have significantly reduced rotavirus hospitalizations and deaths worldwide. However, LORVs are less effective in low- and middle-income countries (LMICs). Next-generation rotavirus vaccines (NGRVs) may be more effective but require administration by injection or a neonatal oral dose, adding operational complexity. Healthcare providers (HPs) were interviewed to assess rotavirus vaccine preferences and identify delivery issues as part of an NGRV value proposition. Determine HP vaccine preferences about delivering LORVs compared to injectable (iNGRV) and neonatal oral (oNGRV) NGRVs. 64 HPs from Ghana, Kenya, Malawi, Peru, and Senegal were interviewed following a mixed-method guide centered on three vaccine comparisons: LORV vs. iNGRV; LORV vs. oNGRV; oNGRV vs. iNGRV. HPs reviewed attributes for each vaccine in the comparisons, then indicated and explained their preference. Additional questions elicited views about co-administering iNGRV+LORV for greater public health impact, a possible iNGRV-DTP-containing combination vaccine, and delivering neonatal doses. Almost all HPs preferred oral vaccine options over iNGRV, with many emphasizing an aversion to additional injections. Despite this strong preference, HPs described challenges delivering oral doses. Preferences for LORV vs. oNGRV were split, marked by disparate views on rotavirus disease epidemiology and the safety, need, and feasibility of delivering neonatal vaccines. Although overwhelmingly enthusiastic about an iNGRV-DTP-containing combination option, several HPs had concerns. HP views were divided on the feasibility of co-administering iNGRV+LORV, citing challenges around logistics and caregiver sensitization. Our findings provide valuable insights on delivering NGRVs in routine immunization. Despite opposition to injectables, openness to co-administering LORV+iNGRV to improve efficacy suggests future HP support of iNGRV if adequately informed of its advantages. Rationales for LORV vs. oNGRV underscore needs for training on rotavirus epidemiology and stronger service integration. Expressed challenges delivering existing LORVs merit further examination and indicate need for improved delivery.

Japanese encephalitis (JE) is a mosquito-borne viral infection of the brain that can cause permanent brain damage and death. In the Philippines, efforts are underway to deliver a live attenuated JE vaccine (CD-JEV) to children under five years of age (YOA), who are disproportionately infected. Multiple vaccination strategies are being considered. We conducted a cost-effectiveness analysis comparing three vaccination strategies to the current state of no vaccination from the societal and government perspectives: (1) national routine vaccination only, (2) sub-national campaign followed by national routine, and (3) national campaign followed by national routine. We developed a Markov model to estimate impact of vaccination or no vaccination over the child’s lifetime horizon, assuming an annual incidence of 10.6 cases per 100,000. Costs of illness ($859/case), vaccine ($0.50/dose), routine vaccination ($0.95/dose), and campaign vaccination ($0.98/dose) were based on hospital financial records, expert opinion and literature. The societal perspective included transportation and opportunity costs of caregiver time, in addition to costs incurred by the health system. JE vaccination via national campaign followed by national routine delivery was the most cost-effective strategy modeled with a cost per disability adjusted life year (DALY) averted of $233 and $29 from the government and societal perspectives, respectively. Results were similar for other delivery strategies with cost/DALY ranging from $233 to $265 from the government perspective and $29–$57 from the societal perspective. JE vaccination was projected to prevent 27,856–37,277 cases, 5571–7455 deaths, and 173,233–230,704 DALYs among children under five over 20 consecutive birth cohorts. Total incremental costs of vaccination versus no vaccination over 20 birth cohorts were $6.6–$9.8 million from the societal perspective ($230 K–$440 K annually) and $45.9–$53.9 million ($2.2 M–$2.7 M annually) from the governmental perspective. Vaccination with CD-JEV in the Philippines is projected to be cost-effective, reducing long-term costs associated with JE illness and improving health outcomes compared to no vaccination.

IntroductionDrug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.ObjectivesTo identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programmes, can better support maternal populations in these countries.DesignScoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.Data sourcesElectronic search of Medline/PubMed, Embase, CINAHL and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.Eligibility criteriaEligible resources included registries, surveillance systems and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.Data extraction and synthesisSearch results were screened and data extracted using a standardised form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorised by resource type.ResultsA total of 7515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in African, Asian and Latin American LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarised according to key features, strengths and weaknesses.ConclusionsThis scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step towards improving safe, world-wide access to life-saving interventions for pregnant populations.Trial registration numberThe protocol for this review has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FU5AT).

Routine infant immunization with live, oral rotavirus vaccines (LORVs) has had a major impact on severe gastroenteritis disease. Nevertheless, in high morbidity and mortality settings rotavirus remains an important cause of disease, partly attributable to the sub-optimal clinical efficacy of LORVs in those settings. Regardless of the precise immunological mechanism(s) underlying the diminished efficacy, the introduction of injectable next-generation rotavirus vaccines (iNGRV), currently in clinical development, could offer a potent remedy. In addition to the potential for greater clinical efficacy, precisely how iNGRVs are delivered (multiple doses to young infants; alongside LORVs or as a booster; co-formulated with Diphtheria-Tetanus-Pertussis (DTP)-containing vaccines), their pricing, and their storage and cold chain characteristics could each have major implications on the resultant health outcomes, on cost-effectiveness as well as on product preferences by national stakeholders and healthcare providers. To better understand these implications, we critically assessed whether there is a compelling public health value proposition for iNGRVs based on potential (but still hypothetical) vaccine profiles. Our results suggest that the answer is highly dependent on the specific use cases and potential attributes of such novel vaccines. Notably, co-formulation of iNGRVs with similar or greater efficacy than LORVs with a DTP-containing vaccine, such as DTP-Hib-HepB, scored especially high on potential impact, cost-effectiveness, and strength of preference by national stakeholders and health care providers in lower and middle income countries.

•Zimbabwe achieved 75-86% HPV vaccine coverage among all 10 to 14 year old girls.•HPV vaccine coverage was slight lower in older aged girls compared to younger.•Cervical cancer protection and trust in vaccines were reasons for high acceptance. Zimbabwe has one of the highest incidence rates of cervical cancer in the world – 61.7 per 100,000 women. The government of Zimbabwe introduced bivalent HPV vaccine with a 0,12 month schedule to all 10–14 year old girls using a pulsed-campaign approach in May 2018 (dose 1) and May 2019 (dose 2). In August 2019, we conducted a population-based, two-stage cluster survey of households with girls who were eligible for the national HPV vaccination program to determine two-dose HPV vaccination coverage in three districts of Zimbabwe. All households with girls currently aged 11 to 15 years were line-listed through a census conducted in the pre-selected clusters from each district prior to survey administration. A simple random sample of eligible households was selected from these lists to estimate HPV vaccine coverage at sufficient power with a margin of error of +/- 5%. Criteria for district selection included estimated vaccine uptake (low, medium, high), rural/urban/peri-urban, geographic area, estimated number of girls not in school, and recent natural disasters or disease outbreaks. We oversampled households with girls aged 13 or 14 years at the time of dose 1. On-time dose 1 uptake ranged from 88 to 94% and two-dose HPV vaccine coverage ranged from 75 to 86% across the three districts. Nearly all vaccinations occurred in schools, and less than 2% of girls did not attend school. There were challenges assessing ages of girls at schools prior to vaccination – 9% of girls vaccinated were less than 10 years old at time of dose 1. Zimbabwe has demonstrated that high uptake and successful completion of 2-dose HPV vaccination can be achieved with an annual dosing schedule. Efforts going forward will need to focus on minimizing dropout between doses and routinizing annual vaccinations in schools for every subsequent new cohort of eligible girls in the country.

BackgroundSocioeconomic deprivation is associated with health inequality. Previous studies have described associations between primary care prescribing rates and deprivation for individual drugs or drug classes. We explore the correlation between socioeconomic deprivation and the rate of prescribing of individual pharmaceutical drugs, and drug classes, in primary care in England, to identify prescribing inequalities that would require further investigation.MethodsIn this cross-sectional study, national primary care prescribing data, by primary care practice, were retrieved for the calendar year 2019 in England. Socioeconomic deprivation was quantified using the Index of Multiple Deprivation (IMD) score. Correlations were calculated using Spearman’s rank correlation coefficient (ρ), adjusting for practice list size and demographics, with a Bonferroni-corrected p value threshold of 5×10–5.ResultsWe included 1.05 billion prescription items dispensed from 6896 England practices. 142/206 (69%) drug classes and 505/774 (65%) drugs were significantly correlated with IMD score (p<5×10−5). Of the 774 included drugs, 31 (4%) were moderately positively associated with IMD score (ρ>0.4). Only one was moderately negatively correlated with IMD score (ρ<−0.4), suggesting higher prescribing rates in more affluent areas. The drug classes most strongly associated with IMD score included opioid and non-opioid analgesics, antipsychotics and reflux medications. Drug classes most strongly associated with affluence included epinephrine, combined oral contraceptives and hormone replacement therapy.ConclusionWe identify novel associations of prescribing with deprivation. Further work is required to identify the underlying reasons for these associations so that appropriate interventions can be formulated to address drivers of inequality.

•An effective and affordable injectable rotavirus vaccine may be attractive to LMICs.•Co-administering oral and injectable vaccines is acceptable to many stakeholders.•Oral vaccine with a birth dose is favored over a higher cost, standalone injectable.•Providing rotavirus vaccine in a DTP combination is the most preferred option. Currently available live, oral rotavirus vaccines (LORVs) have significantly reduced severe rotavirus hospitalizations and deaths worldwide. However, LORVs are not as effective in low- and middle-income countries (LMIC) where rotavirus disease burden is highest. Next-generation rotavirus vaccine (NGRV) candidates in development may have a greater public health impact where they are needed most. The feasibility and acceptability of possible new rotavirus vaccines were explored as part of a larger public health value proposition for injectable NGRVs in LMICs. To assess national stakeholder preferences for currently available LORVs and hypothetical NGRVs and understand rationales and drivers for stated preferences. Interviews were conducted with 71 national stakeholders who influence vaccine policy and national programming. Stakeholders from Ghana, Kenya, Malawi, Peru, Senegal, and Sri Lanka were interviewed using a mixed-method guide. Vaccine preferences were elicited on seven vaccine comparisons involving LORVs and hypothetical NGRVs based on information presented comparing the vaccines’ attributes. Reasons for vaccine preference were elicited in open-ended questions, and the qualitative data were analyzed on key preference drivers. Nearly half of the national stakeholders interviewed preferred a highly effective standalone, injectable NGRV over current LORVs. When presented as having similar efficacy to the LORV, however, very few stakeholders preferred the injectable NGRV, even at substantially lower cost. Similarly, a highly effective standalone injectable NGRV was generally not favored over an equally effective oral NGRV following a neonatal-infant schedule, despite higher cost of the neonatal option. An NGRV-DTP-containing combination vaccine was strongly preferred over all other options, whether delivered alone with efficacy similar to current LORVs or co-administered alongside an LORV (LORV + NGRV-DTP) to increase efficacy. Results from these national stakeholder interviews provide valuable insights to inform ongoing and future NGRV research and development.

Cervical cancer is the second most common cancer among women in the Philippines. Human papillomavirus (HPV) vaccination provides protection from the most common cancer-causing HPV types. This analysis used a proportionate outcomes model to estimate the potential cost-effectiveness of four different HPV vaccine products—Cervarix™, Cecolin®, GARDASIL®, and GARDASIL®9—for routine HPV vaccination of 10 cohorts of 9-year-old girls from the government and societal perspectives. Model parameters included cervical cancer burden, healthcare and program costs, vaccine efficacy with and without potential cross-protection, and vaccination coverage. Univariate and probabilistic sensitivity analyses evaluated the impact of uncertainty on model results. Compared to no vaccination, HPV programs with Cecolin®, Cervarix™, and GARDASIL® are projected to be cost-effective at US$1,210, US$1,300, and US$2,043 per DALY averted, respectively, from the government perspective, and at US$173, US$263, and US$1,006 per DALY averted, respectively, from the societal perspective when cross-protection was considered. When direct comparisons were made across vaccines, GARDASIL® was dominated by Cervarix™ and Cecolin®. In a scenario where cross-protection was not considered, results were similar except that Cervarix™ and GARDASIL® were both dominated by Cecolin®. GARDASIL®9 was not cost-effective under any of the modeled scenarios.

Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group’s participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

Japanese encephalitis (JE) virus is the leading cause of vaccine-preventable encephalitis and a significant cause of disability in Asia and the western Pacific. Many countries have introduced JE vaccination programs, including several low resource countries following WHO's prioritization of JE vaccination in 2006. We sought to characterize the public health impact of JE vaccination programs. JE case data and vaccination coverage rates, were requested from country health officials in 23 JE endemic countries and Chinese Taipei. Additional data were extracted from meeting presentations and published literature. JE incidence was compared before and after vaccination using a minimum three year period pre and post program introduction or expansion. Data suitable for analysis were available for 13 JE-endemic countries and Chinese Taipei, for either all age groups or for children aged under 15 years only. Five countries and Chinese Taipei introduced vaccine prior to 2006 and the all-age JE incidence was reduced by 73-100% in about 5-20 years following introduction. Six countries have introduced JE vaccine since 2006, and JE incidence in children aged younger than 15 years has been reduced by 14-79% as of 2015-2021. JE-specific data were unavailable before introduction in Thailand and Vietnam, but vaccination programs reduced acute encephalitis incidence by 80% and 74%, respectively. Even in the programs with greatest impact, it took several years to achieve their results. JE vaccination has greatly reduced JE in 13 JE-endemic countries and Chinese Taipei. Highest impact has been observed in countries that introduced prior to 2006, but it often took roughly two decades and substantial resources to achieve that level of success. For greatest possible impact, more recently introducing countries and funding agencies should commit to continuous improvements in delivery systems to sustain coverage after initial vaccine introduction.